SARCOFUNC: Sarcopenia Cut-points and Functionality in Older Adults

Sponsor

University of Valencia (Other)

Overall Status

Completed

CT.gov ID

NCT03832608

Collaborator

(none)

300

Enrollment

Location

26.7

Actual Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a cross-sectional study conducted in older adults living in Valencia Province in order to establish the cut-off points of the multicriteria diagnostic of sarcopenia through functionality and frailty variables.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia Diagnostic	Other: No intervention

Detailed Description

Sarcopenia is a geriatric syndrome that involves a gradual and generalized loss of the mass and strength of the skeletal muscles. Currently, there is an international debate about the criteria and reference values for the sarcopenia diagnosis, and the main scientific societies encourage improving research on this. The biggest problem lies in the assessment of the diagnostic criterion of muscle mass while the criterion of muscular strength seems safer and more robust. Experts point out the need to adjust the muscle mass indexes to the characteristics of the population studied, and the convenience of relating the three diagnostic criteria of sarcopenia (muscle mass and strength, and walking speed) with other variables that report about functionality and frailty in older adults.

The main objective is to establish different cut-off points for the diagnostic criteria of sarcopenia and relate them with other instruments for assessing functionality in older population of Valencia Province.

To this purpose, data will be collected through various tests and questionnaires about:

clinical, demographic and anthropometric characteristics; muscle mass; muscle strength; walk speed; physical and cognitive function; nutritional status; self-perception of health; comorbidity and frailty. With this information it will be possible, as primary outcome, to determine a more sensitive, reliable and valid muscle mass index to predict sarcopenia, and, as a secondary outcome, to establish the relationship between the multicriteria diagnostic of sarcopenia with the functional and frailty variables.

Study Design

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Relationship Between the Sarcopenia Diagnostic Cut-points and Functionality in Older Adults

Actual Study Start Date :

Jan 8, 2019

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Older adults and Sarcopenia Older adults with and without Sarcopenia living in Valencia Province.	Other: No intervention There is not intervention to be administered, only collection of data through various tests and questionnaires.

Arm

Intervention/Treatment

Older adults and Sarcopenia

Older adults with and without Sarcopenia living in Valencia Province.

Other: No intervention

There is not intervention to be administered, only collection of data through various tests and questionnaires.

Outcome Measures

Primary Outcome Measures

First criteria of sarcopenia diagnostic: hand grip strength [The cohort group will be assessed in one day visit.]
Muscle strength measured by the isometric hand grip strength (reference: Age and Aging. 2010;39:412-23).
First criteria of sarcopenia diagnostic: knew extension strength [The cohort group will be assessed in one day visit.]
Muscle strength measured by the isometric knew extension (reference: Phys Ther. 1996;76(3):248-59).
First criteria of sarcopenia diagnostic: elbow flexion strength [The cohort group will be assessed in one day visit.]
Muscle strength measured by the isometric elbow flexion (reference: Phys Ther. 1996;76(3):248-59).
Second criteria of sarcopenia diagnostic: muscle mass [The cohort group will be assessed in one day visit.]
Muscle mass estimated by Bioimpedance analysis (BIA) (reference: J Aging Phys Act. 2015;23(4):597-606).
Third criteria of sarcopenia diagnostic: walk speed [The cohort group will be assessed in one day visit.]
Walk speed measured by the Short Physical Performance Balance test (SPPB) (reference: J Gerontol A Biol Sci Med Sc 2000; 55(4):M221-31.

Secondary Outcome Measures

Functionality: Modified Baecke Questionnaire [The cohort group will be assessed in one day visit.]
Functionality measured by the Modified Baecke Questionnaire (reference: Med Clin.2007;129:326-32). The Modified Baecke Questionnaire results in a score to classify people as high, moderate, or low in daily physical activity, based on tertiles. Work Index = 0 1 +12 + 13 + 14 + 15 + 16 + 17 + I8)/8 Sport Index = 0 9 + 110 + II1 + I12)/4 Leisure Time Index = 0 ' 3 + 114 + 115 + 116 + 117 + 118 + I19V7 Total Index = work index + sports index + leisure time index.
Functionality: Barthel Index [The cohort group will be assessed in one day visit.]
Functionality measured by the Barthel Index (reference: Rev Esp Geriatr Gerontol.1993;28:32-40). Range from 0 to 100 score. High score of 100 means total independent.
Functionality: Lawton and Brody Questionnaire [The cohort group will be assessed in one day visit.]
Functionality measured by the Lawton and Brody Questionnaire (reference: Gerontologist.1969;9:179-86).Range from 0 to 8 score. High score of 8 means total independent to perform daily activities.
Frailty: Fried Scale [The cohort group will be assessed in one day visit.]
Frailty measured by the Fried Scale (reference: J Gerontol A Biol Sci Med Sc. 2001;56(3):M146-56). It is a scale with 5 domains: weight loss, self-reported exhaustion, physical activity, walking speed, and weakness. It has a total score ≥ 5 points. A frail person is who scores 3 to 5; is prefrail when scores is 1 to 2, and robust if scores is 0.
Frailty:Frail Scale [The cohort group will be assessed in one day visit.]
Frailty measured by the Frail Scale (reference: J Nutr Health Aging. 2012;16(7):601-8). It has a total score of 5 points. The more score the more frailty. As in Fried scale, participants with scores 3 to 5 is frail person; with scores 1 to 2 is prefrail, and robust if scores is 0.
Frailty: Kihon Check List (KCL) [The cohort group will be assessed in one day visit.]
Frailty measured by the Kihon Check List (reference: Geriatr Gerontol Int. 2016;16(6):709-15). The KCL is a simple self-reporting yes/no survey consisting of 25 questions structured into seven domains /dimensions. A total score ≥ 10 points allow to identify a frail person and each domain can identify the specific need.
Comorbidity [The cohort group will be assessed in one day visit.]
Comorbidity measured by Abbreviated Charslon Index (reference: J Chron Dis.1987;40:373-83). Range from 0 to 10 score. High score of 10 means high comorbidity; 0 means absence of comorbidity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

People aged > 65 years
Residents in Valencia Province (Living-Community, Day-Centers and institutionalized)

Exclusion Criteria:

Lobo Mini-exam cognoscitive < 18 score
Any disorder that prevents from performing the assessment tests.
Recent hospitalization or who are in a acute process of any illness (less one month).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Armonea Group	Valencia		Spain	46015

Sponsors and Collaborators

University of Valencia

Investigators

Principal Investigator: Maria A Cebrià i Iranzo, PT, PhD, University of Valencia
Study Chair: Mercè Balasch i Bernat, PT, PhD, University of Valencia
Study Chair: Anna Arnal Gómez, PT, PhD, University of Valencia
Study Chair: Trinidad Sentandreu Mañó, PT, PhD, University of Valencia
Study Chair: Maria A Tortosa Chuliá, PhD, University of Valencia
Study Chair: Natalia Cezón Serrano, PT, University of Valencia
Study Chair: Jose M Tomás, PhD, University of Valencia
Study Chair: Silvia Forcano Sanjuán, MD, Hospital Universitari i Politècnic La Fe (Valencia)